Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Additional Information about Patents

  • Patent information is published on or after the submission date as defined in 21 CFR 314.53(d)(5).
  • Patent listings published prior to August 18, 2003, only identify method-of-use claims. The listed patents may include drug substance and/or drug product claims that are not indicated in the listing.
  • As of December 5, 2016, an NDA holder submitting information on a patent that claims both the drug substance and the drug product (and is eligible for listing on either basis) is required only to specify that it claims either the drug substance or the drug product. Orange Book users should not rely on an Orange Book patent listing, regardless of when first published, to determine the range of patent claims that may be asserted by an NDA holder or patent owner.

Patent and Exclusivity for: N021856

Product 001
FEBUXOSTAT (ULORIC) TABLET 40MG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 5614520 03/25/2019 DS DP
U-954 CHRONIC MANAGEMENT OF HYPERURICEMIA IN PATIENTS WITH GOUT. NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA
001 6225474 06/18/2019 DS
001 7361676 03/08/2024 DP
001 8372872 09/08/2031
U-1346 USE OF FEBUXOSTAT FOR THE MANAGEMENT OF HYPERURICEMIA IN PATIENTS SUFFERING FROM GOUT AND, WHEN USED WITH THEOPHYLLINE WITHOUT THE NEED FOR DOSE ADJUSTMENT OF THEOPHYLLINE
02/26/2013
001 9107912 09/08/2031
U-1346 USE OF FEBUXOSTAT FOR THE MANAGEMENT OF HYPERURICEMIA IN PATIENTS SUFFERING FROM GOUT AND, WHEN USED WITH THEOPHYLLINE WITHOUT THE NEED FOR DOSE ADJUSTMENT OF THEOPHYLLINE
09/03/2015

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001
M-205 INFORMATION ADDED TO THE LABELING REGARDING RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDIES ON PATIENTS WITH SEVERE RENAL IMPAIRMENT
COMPETITIVE GENERIC THERAPY
08/15/2020

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